Licenses and Regulatory Approvals Needed to Run a Cosmetic Business

Once you have got your trademark registration and website domain ready for your cosmetic brand the next step will be to get licenses and regulatory approvals to run your cosmetic business. Cosmetic license is required for manufacturing and exporting of cosmetics. Besides, it is also essential for international companies willing to set up manufacturing hubs in India. 

The Cosmetics Rules 2020 highlights the rules for cosmetics registration in India.  It defines the word “Cosmetic” as an “article that intends to be, poured sprinkled rubbed or sprayed or introduced into or otherwise applied to any human body or any part thereof for cleansing, beautifying, promoting attractiveness or altering the appearance and also includes an article intended to use as a component of cosmetic”. 

Types of Cosmetic Registration in India

Here are the license that is required for cosmetic product manufacturing and market in India according to D & C Act, 1940;

  • License in Form no 32 is issued for manufacturing cosmetics for sale or distribution and the application is filed in Form no 31.
  • License in Form 32-A is issued for loan license for manufacturing cosmetics for sale. The application is filed in form no 31-A. 
  • The license on Form 37 is issued for grant or renewal of approval for carrying out tests on drugs or cosmetic or raw material used in the manufacturing on behalf of license for manufacture for sale of drugs and cosmetics.
  • An importer cosmetic registration is required when we do not manufacture the cosmetic but import and resale it in India.

Benefits of Cosmetic Registration in India

Builds Reputation

The cosmetics license and registration will make your brand authentic and accountable. This will enhance the reputation of your company thereby increasing sales and turnover. 

Government Compliance 

The registration of your cosmetic brand will make it government compliant that will add credibility and authenticity to your cosmetic brand. 

Protection of your brand 

The cosmetics license registration will increase the protection of your cosmetic products. You can also protect your product from intellectual property infringement. 

Regulatory Authority/ Body for Cosmetic Registration in India

The primary regulatory authority or body for Cosmetic Registration in India is the Central Drug Standard Control Organization (CDSCO). All cosmetic licenses and drugs are regulated by this body.  All the requirements related to registration are required to be regulated by this authority. The law which regulates cosmetic businesses in India is the Drug and Cosmetic Act 1940 & Rules 1945(including the amendment in cosmetics rules 2020).Moreover, the BIS (Bureau of Indian Standards) regulates the ingredients of your cosmetic products. 

Cosmetic Regulations in India for Cosmetic license

Under the Cosmetics Rule 2020/Drugs and Cosmetic Rules, 1945, Schedule M-II classifies cosmetics into 11 broad products categories;

  • Powders
  • Creams, lotions, cleansing, milk, shampoos, shaving creams, hair oils etc
  • Nail polishes and Nail lacquers
  • Lipsticks and Lip-gloss
  • Depilatories
  • Preparations used for eyes
  • Aerosol
  • Alcoholic Fragrance Solutions
  • Hair Dyes
  • Tooth powder and toothpaste
  • Toilet soaps

The manufacturer must ensure that the production of the cosmetic products is done in the presence of a skilled and competent technical staff and at least one of the staff people should possess the following educational requirements;

  • holds a diploma in pharmacy by the Pharmacy Council of India under the Pharmacy Act, 1948 or
  • registered under the Pharmacy Act, 1948 
  • The Licensing Authority is required to inspect the entire premises where the operation is to be carried out. Besides, the Inspection officer needs to submit the complete report to the Licensing Authority which will decide whether to grant the license or not.

Labeling of products and regulation for Manufacturer

A glance at the labeling requirements under the Cosmetics Rules, 2020

  • The name of the product should be clearly mentioned on both the inner and the outer labels. The outer label should clearly display the ingredients that are used in the manufacturing of the products.
  • The inner label must contain the direction for use along with the warning or cautions that may be necessary.
  • A separate batch number preceded by letter “B” and manufacturing batch with “M” must be stated on the label.
  • The Bureau of Indian Standards (BIS) checks the quality of the product every so often and also revises as per the requirement of Indian standard.

Documents Required for Cosmetic Registration in India

  • In case you are an importer the original copy of Power of Attorney will be required. 
  • Certificate of free sale, marketing authorization letter
  • Form 42 duly signed and filed and the list of products to be renewed. 
  • A self-declaration that there are no changes in earlier shred information.
  • NOC from Pollution Control Board
  • Plan the layout of the premises
  • Rent agreement in case of rented premises
  • List of laboratory equipment
  • Affidavit of Applicant
  • List of machines installed for manufacturing
  • The Importer needs to apply for cosmetic registration products. 
  • An authorized agent of the manufacturer
  • A Subsidiary of the manufacturer
  • A manufacturer having registered premises in India. 
  • Each and every product that is manufactured or imported should conform to the Drugs and Cosmetics Rules, 1945 and the registration is valid for the period of three years.

The cosmetic rules and regulations must be followed for product development, stability, safety, quality and efficacy of the cosmetic products. 

To safeguard and protect the consumer there is a need to enhance the regulations pertaining to control standards and safety information for cosmetics in India to ensure safe finished cosmetic products. 

Get started by click here to read our next blog on How to develop a high quality cosmetic product that will spellbound your customer to buy your products.

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Dr Saurabh Arora

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